Status:
COMPLETED
Effectiveness of an Extended Release Stimulant Medication in Treating Preschool Children With ADHD
Lead Sponsor:
Baystate Medical Center
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Attention Deficit Disorder With Hyperactivity
Eligibility:
All Genders
36-66 years
Phase:
NA
Brief Summary
This study will evaluate the safety and effectiveness of extended release mixed amphetamine salts in treating preschool children with attention deficit hyperactivity disorder.
Detailed Description
Attention deficit hyperactivity disorder (ADHD) is a common developmental disorder that affects between 4% and 12% of school-aged children. Children with ADHD often show symptoms of hyperactivity, ina...
Eligibility Criteria
Inclusion
- Living at home for at least 6 months with parent or caregiver
- Enrolled in a structured school setting at least 2 half days a week with a minimum of 7 peers
- Full Scale Intelligence Quotient (FSIQ) of 70 or greater OR 72 or greater if bilingual
- Best estimate diagnosis based on clinical interview, Diagnostic Interview Schedule for Children, Child Behavior Checklist, and rating scales scores
- Symptoms present for at least 9 months
- Meets severity criteria for Clinical Global Impression-Severity with score of greater than or equal to 4 and Clinical Global Assessment Scale score of greater than or equal to 55
- Parent/caregiver can commit to 6 weekly sessions, including initial screening exams
- If on current psychotropic medication, will undergo a washout period of at least 3 days before study entry
- Not currently receiving psychotherapy or started psychotherapy within 30 days of study entry
Exclusion
- Previous nonresponse to mixed amphetamine salts (defined as 2 weeks of persistent symptoms in spite of doses greater than or equal to 15 mg per day)
- Diagnosis of language-based or cognitive delay of more than 2 standard deviations below same-aged peers or diagnosis of mental retardation
- Pervasive developmental disorder or autism
- Significant developmental disorder (e.g., blindness, deafness, cerebral palsy, epilepsy, psychosis)
- Taking another psychotropic medication that cannot be discontinued
- Serious psychiatric disorder (e.g., bipolar, suicidality, tic disorder)
- Actively taking medication for certain medical conditions (e.g., hypertension, structural cardiac condition, glaucoma, hyperthyroidism)
- Allergy to mixed amphetamine salts
- History of physical, sexual, or emotional abuse that is clinically significant
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00712699
Start Date
June 1 2008
End Date
August 1 2010
Last Update
August 23 2013
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